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Updated: May 8, 2026
The WATCHMAN Left Atrial Appendage Closure Device for Atrial Fibrillation
Published on: February 28, 2012
Prognostic Impact of Left Atrial Appendage Patency After Device Closure
Mu Chen1, Peng-Cheng Yao1, Zhen-Tao Fei1
1Department of Cardiology, Xinhua Hospital, School of Medicine, Shanghai Jiao Tong University, China.
Insights
Left atrial appendage (LAA) patency after WATCHMAN device closure increases stroke risk in atrial fibrillation patients. Even small leaks impact prognosis, highlighting the need for careful monitoring and management.
Area of Science:
- Cardiology
- Medical Devices
- Interventional Procedures
Background:
- Prognostic impact of left atrial appendage (LAA) patency post-LAA closure in atrial fibrillation (AF) patients is not fully understood.
- Visible peri-device leak (PDL) is a known complication, but its significance alongside LAA patency requires further investigation.
Purpose of the Study:
- To evaluate the prognostic significance of LAA patency, with or without PDL, after WATCHMAN 2.5 device implantation in AF patients.
- To identify risk factors associated with adverse events in patients with LAA patency.
Main Methods:
- Prospective enrollment of 519 AF patients receiving WATCHMAN 2.5 device.
- Cardiac computed tomography angiography (CCTA) at 3 months for LAA surveillance.
- Comparison of adverse events (stroke/TIA, bleeding, death, MAEs) between complete closure and LAA patency groups.
Main Results:
- LAA patency observed in 47.8% of patients (37.8% with PDL, 10.0% without).
- LAA patency significantly increased risks of stroke/TIA (aHR 3.22) and MAEs (aHR 1.12).
- Increased PDL size correlated with higher incidences of stroke/TIA, cardiovascular death, and MAEs.
Conclusions:
- LAA patency detected by CCTA at 3 months post-closure is linked to poorer outcomes in AF patients with WATCHMAN devices.
- Visible PDL, regardless of size, is associated with increased stroke/TIA and MAE risks.
- Older age and cessation of antiplatelet therapy predict adverse events in patients with LAA patency.
Background:
The prognostic impact of left atrial appendage (LAA) patency, including those with and without visible peri-device leak (PDL), post-LAA closure in patients with atrial fibrillation, remains elusive.
Methods:
Patients with atrial fibrillation implanted with the WATCHMAN 2.5 device were prospectively enrolled. The device surveillance by cardiac computed tomography angiography was performed at 3 months post-procedure. Adverse events, including stroke/transient ischemic attack (TIA), major bleeding, cardiovascular death, all-cause death, and the combined major adverse events (MAEs), were compared between patients with complete closure and LAA patency.
Results:
Among 519 patients with cardiac computed tomography angiography surveillance at 3 months post-LAA closure, 271 (52.2%) showed complete closure, and LAA patency was detected in 248 (47.8%) patients, including 196 (37.8%) with visible PDL and 52 (10.0%) without visible PDL. During a median of 1193 (787-1543) days follow-up, the presence of LAA patency was associated with increased risks of stroke/TIA (adjusted hazard ratio for baseline differences, 3.22 [95% CI, 1.17-8.83]; P=0.023) and MAEs (adjusted hazard ratio, 1.12 [95% CI, 1.06-1.17]; P=0.003). Specifically, LAA patency with visible PDL was associated with increased risks of stroke/TIA (hazard ratio, 3.66 [95% CI, 1.29-10.42]; P=0.015) and MAEs (hazard ratio, 3.71 [95% CI, 1.71-8.07]; P=0.001), although LAA patency without visible PDL showed higher risks of MAEs (hazard ratio, 3.59 [95% CI, 1.28-10.09]; P=0.015). Incidences of stroke/TIA (2.8% versus 3.0% versus 6.7% versus 22.2%; P=0.010), cardiovascular death (0.9% versus 0% versus 1.7% versus 11.1%; P=0.005), and MAEs (4.6% versus 9.0% versus 11.7% versus 22.2%; P=0.017) increased with larger PDL (0, >0 to ≤3, >3 to ≤5, or >5 mm). Older age and discontinuing antiplatelet therapy at 6 months were independent predictors of stroke/TIA and MAEs in patients with LAA patency.
Conclusions:
LAA patency detected by cardiac computed tomography angiography at 3 months post-LAA closure is associated with unfavorable prognosis in patients with atrial fibrillation implanted with WATCHMAN 2.5 device.
Registration:
URL: https://www.clinicaltrials.gov; Unique identifier: NCT03788941.
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